Table 1.
Safety summary: pooled data for MONARCH 2 and MONARCH 3 showing any‐grade, grade 3, and grade 4 adverse events occurring in ≥10% of patients in the abemaciclib or placebo arms
| Preferred term | Abemaciclib plus fulvestrant or NSAI (n = 768) | Placebo plus fulvestrant or NSAI (n = 384) | ||||
|---|---|---|---|---|---|---|
| Any grade | Grade 3 | Grade 4 | Any grade | Grade 3 | Grade 4 | |
| Diarrhea | 650 (84.6) | 90 (11.7) | 0 (0) | 107 (27.9) | 3 (0.8) | 0 (0) |
| Neutropenia | 346 (45.1) | 176 (22.9) | 19 (2.5) | 12 (3.1) | 4 (1.0) | 2 (0.5) |
| Nausea a | 334 (43.5) | 16 (2.1) | — | 84 (21.9) | 4 (1.0) | — |
| Fatigue a | 311 (40.5) | 18 (2.3) | — | 114 (29.7) | 1 (0.3) | — |
| Abdominal pain a | 258 (33.6) | 17 (2.2) | — | 56 (14.6) | 4 (1.0) | — |
| Anemia | 231 (30.1) | 54 (7.0) | 1 (0.1) | 21 (5.5) | 4 (1.0) | 0 (0) |
| Vomiting | 213 (27.7) | 9 (1.2) | 0 (0) | 44 (11.5) | 8 (2.1) | 0 (0) |
| Decreased appetite | 203 (26.4) | 10 (1.3) | 0 (0) | 44 (11.5) | 2 (0.5) | 0 (0) |
| Leukopenia | 197 (25.7) | 65 (8.5) | 2 (0.3) | 8 (2.1) | 0 (0) | 1 (0.3) |
| Alopecia b | 159 (20.7) | — | — | 22 (5.7) | — | — |
| Headache | 154 (20.1) | 6 (0.8) | — | 60 (15.6) | 1 (0.3) | — |
| Blood creatinine increased | 119 (15.5) | 10 (1.3) | 1 (0.1) | 8 (2.1) | 0 (0) | 0 (0) |
| Constipation | 117 (15.2) | 5 (0.7) | 0 (0) | 53 (13.8) | 1 (0.3) | 0 (0) |
| Alanine aminotransferase increased | 116 (15.1) | 37 (4.8) | 2 (0.3) | 24 (6.3) | 7 (1.8) | 0 (0) |
| Dysgeusia b | 110 (14.3) | — | — | 11 (2.9) | — | — |
| Thrombocytopenia | 110 (14.3) | 17 (2.2) | 8 (1.0) | 11 (2.9) | 1 (0.3) | 1 (0.3) |
| Aspartate aminotransferase increased | 109 (14.2) | 22 (2.9) | 0 (0) | 27 (7.0) | 8 (2.1) | 0 (0) |
| Arthralgia a | 108 (14.1) | 1 (0.1) | — | 65 (16.9) | 1 (0.3) | — |
| Stomatitis | 108 (14.1) | 2 (0.3) | 0 (0) | 40 (10.4) | 0 (0) | 0 (0) |
| Cough a | 107 (13.9) | 0 (0) | — | 45 (11.7) | 0 (0) | — |
| Pruritus a | 104 (13.5) | 0 (0) | — | 28 (7.3) | 0 (0) | — |
| Dizziness a | 99 (12.9) | 4 (0.5) | — | 31 (8.1) | 0 (0) | — |
| Rash | 99 (12.9) | 8 (1.0) | 0 (0) | 18 (4.7) | 0 (0) | 0 (0) |
| Back pain a | 94 (12.2) | 6 (0.8) | — | 54 (14.1) | 3 (0.8) | — |
| Dyspnea | 88 (11.5) | 13 (1.7) | 2 (0.3) | 36 (9.4) | 4 (1.0) | 0 (0) |
| Edema peripheral a | 84 (10.9) | 0 (0) | — | 25 (6.5) | 0 (0) | — |
| Pyrexia | 82 (10.7) | 3 (0.4) | 1 (0.1) | 30 (7.8) | 1 (0.3) | 0 (0) |
| Upper respiratory tract infection | 82 (10.7) | 0 (0) | 0 (0) | 26 (6.8) | 2 (0.5) | 0 (0) |
| Weight decreased a | 82 (10.7) | 4 (0.5) | — | 10 (2.6) | 2 (0.5) | — |
| Hot flush a | 79 (10.3) | 0 (0) | — | 50 (13.0) | 0 (0) | — |
Data are presented as n (%).
Additional adverse events of clinical importance but with incidence <10% are described here: (a) Interstitial lung disease/pneumonitis [abemaciclib arm: any grade, 26 (3.4); grade ≥3, 7 (0.9%); placebo arm: any grade, 2 (0.5%); grade ≥3, 0 (0%)] and (b) venous thromboembolic events: [abemaciclib arm: any grade, 41 (5.3%); grade ≥3, 19 (2.5%); placebo arm: any grade, 3 (0.8%); grade ≥3, 2 (0.5%)].
Maximum grade 3, so grade 4 is not applicable.
Maximum grade 2, so grades 3 or 4 are not applicable.
Abbreviations: —, no data; NSAI, nonsteroidal aromatase inhibitor.